1. Field of the Invention
The invention relates to a catheter system for implanting embryos into a woman""s uterus. More particularly, this invention concerns such a catheter system utilizing a protective catheter sleeve for introducing a catheter into the uterus without mucus contamination. And it concerns an improved catheter construction for embryo protection and deposit.
2. Description of the Prior Art
Typically, in present fertility clinics, three or four embryos are placed in a tiny, flexible catheter near the opening in the depositing end (the distal end) of the catheter. The catheter is then inserted through the woman""s cervix and the embryos flushed hydraulically from the catheter and, hopefully, the embryos become implanted in the uterus wall. But the small catheter required is difficult to insert and mucus from the mouth of the cervix may be caught at the mouth of the catheter and interfere with the embryos. So, a stiffer and larger sleeve catheter may be used for insertion through the cervix; and then the smaller catheter may be pushed through and out the larger sleeve catheter to implant the embryos. This sleeve use helps, but cervix mucus may still be caught in the introduction end (the distal end) of the larger catheter and then transferred to the smaller catheter, thus still possibly interfering with the embryos.
The prior art includes some catheter-type devices for use in embryo implantation. In particular, Bacich U.S. Pat. No. 5,472,419 and Fischl U.S. Pat. No. 4,790,814 both employ the use of a catheter-type device, each having distal end openings to allow passage of the embryos to the uterus. Though these devices may be used for embryo implantation, they do not adequately address the problem of preventing the accumulation of mucuslike material at the distal end opening, which may interfere with embryo implantation. Other embryo implanting devices employ the use of a catheter enclosed within an outer sleeve. For example, Wallace""s GB No. 2,118,840 employs the use of an inner catheter slidable within an outer sleeve where the distal end of the outer sleeve is open. Though this device might also be suitable for embryo implantation, it fails to teach or implement an efficient way to protect against mucus accumulation within the outer sleeve during insertion. Other medical devices in fields other than embryo implantation employ the use of a catheter enclosed within an outer sleeve. For example, Pokorney U.S. Pat. No. 5,083,572 employs the use of an inner catheter slidable within an outer sleeve for use in obtaining vaginal secretions; but the purpose and construction are to bring in secretions/mucus within the outer sleeve, not to keep them out. And Pokorney""s use of side sampling ports near the distal end of the outer sleeve do not prevent mucus accumulation within the outer sleeve nor does the sleeve permit the inner catheter to slide out of the sleeve to deposit an embryo or for any purpose whatsoever.
Other background art, still further removed from addressing such problems as mucus accumulation during embryo implanting include Kalayjian U.S. Pat. No. 3,513,830, which discloses an instrument for obtaining body cultures. This instrument employs the use of a cotton swab slidable within a plastic sterilizable outer sleeve. The outer sleeve has a friction-fitted cap, outwardly convex, which can be inserted into a body cavity closed and then opened once inside the desired cavity to allow the cotton-tipped swab to project out of the outer sleeve to take a tissue sample. An object of the Kalayjian invention is apparently to prevent the swab from becoming contaminated either before or after the swab comes in contact with the desired tissue. Kalayjian differs from the present invention in many ways: it is not designed for the purpose of embryo implanting; it is not designed to hold an inner catheter (it holds a wooden swab); it is not designed to be xe2x80x9copenedxe2x80x9d by a fragile inner catheter (and might well destroy an emerging inner catheter); the cap/tip is deigned (internally indented) to match the swab; etc. O""Neil, U.S. Pat. No. 4,652,259, is even further afield. It discloses a.urinary catheter assembly and has to do with bacteria protection of the bladder in collecting urine, not mucus and embryo protection for transplanting. The sleeve is built for specific use only in the outer urethra and only the inner catheter is permitted to travel alone through the inner urethra and into the bladder for catheterization. Similarly, Vega, U.S. Pat. No. 4,249,536, discloses a urological catheter with a soft pliable cone-shaped tip (containing spiral grooves or hair-like projections) which can open by means of strings attached to the tip. This device also uses magnetic forces to advance the catheter through the urethra. This device differs in many important ways from the present invention; e.g., the Vega tip opens to a very wide position which could cause significant trauma if used for embryo transfer; the Vega device uses strings to pull open the tip of the catheter, and the tip itself is not a unitary small, light, part of the distal end of the catheter, openable by the pushing of a fragile embryo-transfer type of inner catheter, etc.; and closing such a device is difficult. Whatever end system may be used on a sleeve for embryo transfer, it is obviously vitally important that pieces of the end do not break off and remain in the cervix.
Thus there is a need for a catheter system for implanting embryos which will better protect the embryos from mucus and other damage in an efficient manner.
A primary object of the present invention is to fulfill the above-mentioned needs by the provision of an improved catheter system for implanting embryos. A further primary object of the present invention is to provide such a catheter system which is efficient, inexpensive, and handy. Other objects of this invention will become apparent with reference to the following invention descriptions.
According to a preferred embodiment of the present invention, this invention provides a catheter system for assisting implanting embryos in a uterus, comprising: catheter sleeve means, having a sleeve distal end and a sleeve proximal end and having, between such sleeve distal end and such sleeve proximal end, a longitudinal cylindrical hollow having a central longitudinal axis, such catheter sleeve means being structured and arranged for containing an inner catheter in such cylindrical hollow, such catheter sleeve means comprising end cap means, disposed along an intersection of such central axis at such sleeve distal end, for substantially enclosing such cylindrical hollow at such sleeve distal end to protect such cylindrical hollow from accumulating mucuslike material when such catheter sleeve means is pushed through a cervix, such end cap means comprising end opening means, disposed along such intersection of such central axis at such sleeve distal end, for permitting passage of an inner catheter along such central axis from within such cylindrical hollow into a such uterus; such catheter sleeve means being structured and arranged for travel of such sleeve distal end through the cervix for assistance in implanting embryos.
Further, this invention provides such a system wherein such end opening means of such sleeve distal end comprises swivel means constructed and arranged in such manner that such end cap means swivels outward when an inner catheter is pushed through such sleeve distal end; and, further, wherein such end cap means comprises an outwardly convex flexible end on such catheter sleeve means and such end cap opening means comprises a partial transverse cut separating, except for a remaining transverse hinge portion, such outwardly convex flexible end from such catheter sleeve means, whereby such end cap means is constructed and arranged to swivel outward when an inner catheter is pushed through such sleeve distal end. And it provides such a system further comprising: an inner catheter means, having a catheter distal end and a catheter proximal end, for transporting a such embryo through such cylindrical hollow of such outer sleeve means into access to such uterus and for depositing such embryo in such uterus; and, further, wherein such inner catheter means comprises indicia means for indicating longitudinal distance to assist in attaining a desired implanting location.
Also, this invention provides such a system wherein such catheter distal end comprises: catheter distal opening means for depositing such embryo, such catheter distal opening means comprising a side port, adjacent such catheter distal end of such inner catheter means. And it provides such a system wherein such catheter distal end comprises: second end cap means at such catheter distal end for protecting such inner catheter means when such catheter distal end is pushed through such sleeve distal end; and catheter distal opening means for depositing such embryo, such catheter distal opening means comprising a side port adjacent such second end cap means at such catheter distal end of such inner catheter means; and, further, wherein such catheter distal end further comprises strengthening means opposite such catheter distal opening means for strengthening such inner catheter means against breakage. Also, it provides such a system wherein such end opening means at such sleeve distal end of such catheter sleeve means comprises swivel means constructed and arranged in such manner that such end cap means swivels outward when such catheter distal end is pushed through such sleeve distal end.
In addition, it provides such a system wherein such catheter sleeve means further comprises first stop means for limiting insertion to a desired location when such catheter sleeve means is inserted through the cervix; and, further, wherein such inner catheter means further comprises second stop means settable along such inner catheter means for limiting insertion to a desired implanting location when such inner catheter means is inserted into a such uterus. And it provides such a system wherein such catheter sleeve means further comprises stop means for limiting insertion to a desired location when such catheter sleeve means is inserted into a such uterus.
Even further, in accordance with a preferred embodiment thereof, the present invention provides a catheter system for implanting embryos in a uterus, comprising: a catheter outer sleeve having a longitudinal cylindrical hollow between a sleeve distal end and a sleeve proximal end, for providing safe catheter access to a such uterus by a catheter having a catheter distal end and a catheter proximal end; such sleeve distal end comprising an outwardly convex end cap, for protecting such cylindrical hollow from accumulating mucuslike material when such catheter outer sleeve is pushed through a cervix, and an outwardly-swivelable connection between such end cap and such catheter outer sleeve, for permitting passage of a such catheter distal end from such cylindrical hollow into access to the uterus when such catheter distal end is pushed against such end cap to swivel such end cap outwardly and move such catheter distal end through such sleeve distal end.
Even additionally, this invention provides such a system further comprising: an inner catheter means, having a catheter distal end and a catheter proximal end, for transporting a such embryo through such cylindrical hollow of such outer sleeve into access to such uterus and for depositing such embryo in such uterus. And it provides such a system wherein such catheter distal end comprises: an outwardly convex second end cap for protecting such inner catheter means when such catheter distal end is pushed through such sleeve distal end; and a catheter distal opening for depositing a such embryo, such catheter distal opening comprising a side port adjacent such second end cap. It also provides such a system further comprising: locating means for locating such catheter distal end in a such uterus, such locating means comprising first stop means on such catheter outer sleeve for abutting a cervix entrance to such uterus, and second stop means settable along such inner catheter means for limiting insertion of such catheter distal end of such inner catheter means to a desired implanting location when such inner catheter means is inserted into a such uterus.
Moreover, according to a preferred embodiment of this invention, it provides a catheter system for implanting embryos in a uterus, comprising, in combination, the steps of: providing a catheter outer sleeve having a longitudinal cylindrical hollow between a sleeve proximal end and a sleeve distal end having an outwardly convex end cap and an outwardly-swivelable connection between such end cap and such catheter outer sleeve; providing a catheter having a catheter proximal end and a catheter distal end having an opening for transmission of a such embryo, such catheter being sized for moving through such longitudinal cylindrical hollow; loading at least one such embryo into such catheter distal end; placing such catheter into such sleeve proximal end of such catheter outer sleeve and moving such catheter forward until such catheter distal end is approaching such sleeve distal end; introducing such sleeve proximal end through a cervix to a desired stop location; further moving such catheter forward into such end cap of such catheter outer sleeve, outwardly swiveling such end cap, and further moving such catheter distal end forward into such uterus to a desired implanting location; and flushing such embryo out of such catheter distal end.
It even further provides such a system wherein such catheter distal end of such catheter comprises: a second end cap for protecting such catheter when such catheter distal end is pushed through such sleeve distal end; and a catheter distal opening for depositing a such embryo, such catheter distal opening comprising a side port adjacent such second end cap; and, further, wherein: such catheter outer sleeve further comprises first stop means located along such catheter outer sleeve for limiting insertion to such desired stop location when such catheter outer sleeve is introduced through the cervix; and such catheter further comprises second stop means settable along such catheter for limiting insertion to such desired implanting location when such inner catheter means is inserted into a such uterus.
Even moreover, in accordance with a preferred embodiment thereof, this invention provides, for use in a catheter system for implanting embryos in a uterus, wherein the steps in such system include providing a catheter outer sleeve having a longitudinal cylindrical hollow between a sleeve proximal end and a sleeve distal end having an outwardly convex end cap and an outwardly-swivelable connection between such end cap and such catheter outer sleeve, providing a catheter having a catheter proximal end and a catheter distal end having an opening for transmission of a such embryo, such catheter being sized for moving through such longitudinal cylindrical hollow, loading at least one such embryo into such catheter distal end, placing such catheter into such sleeve proximal end of such catheter outer sleeve and moving such catheter forward until such catheter distal end is approaching such sleeve distal end, introducing such sleeve proximal end through a cervix to a desired stop location, further moving such catheter forward into such end cap of such outer sleeve, outwardly swiveling such end cap, and further moving such catheter distal end forward into such uterus to a desired implanting location, and flushing such embryo out of such catheter distal end, a method of making such outwardly-swivelable connection between such end cap and such outer sleeve, comprising the steps of: providing an outwardly convex end portion at such sleeve distal end integral with such catheter outer sleeve; and cutting to partially sever such end portion from such catheter outer sleeve transversely just beneath such end portion around at least about 200 degrees of a circumference around such convex end portion; whereby an unsevered part of such end portion provides a hinge means comprising such outwardly-swivelable connection.
Also, this invention provides, in accordance with a preferred embodiment thereof, a catheter system for assisting implanting embryos in a uterus wherein such end opening means is a slit, normally closed but openable for permitting passage of a such inner catheter pushed along such central axis from within such cylindrical hollow into access to the uterus. It also provides such a system wherein such end opening means of such sleeve distal end is a cross-cut slit, normally closed but openable for permitting passage of a such inner catheter pushed along such central axis from within such cylindrical hollow into access to the uterus.
Even further, according to a preferred embodiment thereof, this invention provides a catheter system for assisting implanting embryos in a uterus, comprising: catheter sleeve means, having a sleeve distal end and a sleeve proximal end and having, between such sleeve distal end and such sleeve proximal end, a longitudinal cylindrical hollow having a central longitudinal axis, such catheter sleeve means being structured and arranged for containing an inner catheter in such cylindrical hollow, such catheter sleeve means comprising end cap means, disposed along an intersection of such central axis at such sleeve distal end, for substantially enclosing such cylindrical hollow at such sleeve distal end to protect such cylindrical hollow from accumulating mucuslike material when such catheter sleeve means is pushed through a cervix, such end cap means comprising end opening means, disposed along such intersection of such central axis at such sleeve distal end, for permitting passage of an inner catheter along such central axis from within such cylindrical hollow into access to the uterus; said catheter sleeve means being structured and arranged for travel of such sleeve distal end through the cervix for assistance in implanting embryos; and wherein such catheter sleeve means comprises a longitudinal wire-stiffening means for wire-stiffening of such catheter sleeve means. It also provides such a catheter system wherein such wire-stiffening means comprises substantially all of a longitudinal dimension of such catheter sleeve means; and, further, wherein such wire-stiffening means comprises a metal wire; and, further, wherein such metal wire comprises a surface of such longitudinal cylindrical hollow; and, further, wherein such wire-stiffening means is constructed and arranged to permit holding a bent shape and provide shape-maintaining support.
Moreover, according to a preferred embodiment thereof, this invention provides a catheter system for implanting embryos in a uterus, comprising: an inner catheter, having a catheter distal end and a catheter proximal end, structured and arranged to transport the embryos into access to the uterus and to deposit such embryo in the uterus; and a catheter outer sleeve having a longitudinal cylindrical hollow between a sleeve distal end and a sleeve proximal end, structured and arranged to provide safe catheter access to the uterus by such inner catheter; wherein such inner catheter comprises a proximal portion having a larger external diameter than an external diameter of a distal portion of such inner catheter. It also provides such a catheter system wherein such catheter outer sleeve comprises a proximal portion having a larger internal diameter than an internal diameter of a distal portion of such catheter outer sleeve and having a thicker wall than the wall of such distal portion of such catheter outer sleeve.
And it provides such a catheter system wherein a distal end of such distal portion of such catheter outer sleeve comprises more flexible material than a remainder of such distal portion of such catheter outer sleeve, whereby such catheter outer sleeve comprises at least three different stiffnesses along such longitudinal hollow cylinder, in increasing-stiffness order from such distal end to such proximal end of such longitudinal hollow cylinder; and, further, wherein such proximal portion of such inner catheter is at least as long as such proximal portion of such catheter outer sleeve; and, further, wherein such proximal portion of such catheter outer sleeve is at least about 10 centimeters long; and, further, wherein such distal portion of such catheter outer sleeve is at most about 5 centimeters long.
Yet moreover, according to a preferred embodiment thereof, this invention provides a catheter system for assisting implanting embryos in a uterus, comprising: a catheter outer sleeve having a sleeve distal end and a sleeve proximal end and having, between such sleeve distal end and such sleeve proximal end, a longitudinal cylindrical hollow having a central longitudinal axis, such catheter outer sleeve being structured and arranged to contain an inner catheter in such cylindrical hollow, such catheter outer sleeve comprising a longitudinal wire-stiffener structured and arranged to stiffen such catheter outer sleeve; said catheter outer sleeve being structured and arranged to permit travel of such sleeve distal end through a cervix to assist in implanting embryos; wherein such catheter outer sleeve comprises a proximal portion having a larger internal diameter than an internal diameter of a distal portion of such catheter outer sleeve; and, further, wherein such wire-stiffener comprises substantially all of a longitudinal dimension of such catheter outer sleeve. And it provides such a catheter system further comprising an inner catheter, having a catheter distal end and a catheter proximal end, structured and arranged to transport the embryos into access to the uterus and to deposit the embryos in the uterus; and, further, wherein such inner catheter comprises a proximal portion having a larger external diameter than an external diameter of a distal portion of such inner catheter; and, further, wherein such proximal portion of such inner catheter is at least as long as such proximal portion of such catheter outer sleeve. And it provides such a catheter system wherein such catheter outer sleeve comprises an end cap, disposed along an intersection of such central axis at such sleeve distal end, to substantially enclose such cylindrical hollow at such sleeve distal end to protect such cylindrical hollow from accumulating mucuslike material when such catheter outer sleeve is inserted into the uterus, such end cap comprising an end opener, disposed along such intersection of such central axis at such sleeve distal end, to permit passage of a such inner catheter along such central axis from within such cylindrical hollow into the uterus.
Yet in addition, according to a preferred embodiment thereof, this invention provides a catheter system for implanting embryos in a uterus, comprising: a catheter outer sleeve having a longitudinal cylindrical hollow between a sleeve distal end and a sleeve proximal end, structured and arranged to provide safe catheter access to the uterus by an inner catheter having a catheter distal end and a catheter proximal end; said sleeve distal end comprising an internally substantially-non-concave end cap, structured and arranged to protect such cylindrical hollow from accumulating mucuslike material when such catheter outer sleeve is pushed through a cervix, and an outwardly-swivelable connection between such end cap and such catheter outer sleeve, such sleeve distal end being structured and arranged to permit non-destructive passage of a such catheter distal end from such cylindrical hollow into access to the uterus when such catheter distal end is pushed against such internally substantially-non-concave end cap, thereby swiveling such end cap outwardly and moving such catheter distal end through such sleeve distal end.
And it provides such a catheter system wherein said outwardly-swivelable connection is a unitary part of such sleeve distal end; and, further, wherein such catheter outer sleeve comprises a long metal tube connected to a short plastic distal end comprising such swivelable end cap; and, further, wherein such outwardly-swivelable connection is a unitary part of such sleeve distal end, and such end cap is a unitary part of such sleeve distal end. It further provides such a catheter system wherein an internal surface of such internally substantially-non-concave end cap lies substantially within a single flat plane; and, further, wherein said internally substantially-non-concave end cap is outwardly convex. Also, this invention provides such a catheter system wherein such sleeve distal end further comprises mucus-trapping means for trapping nearby mucus during a such passage of a such catheter distal end from such cylindrical hollow into access to the uterus; and, further, wherein such mucus-trapping means comprises roughened surface portions to assist in such.trapping of mucus. And it provides such a catheter system wherein such roughened surface portions comprise both external and internal surfaces of such sleeve distal end; and, further, wherein such end cap comprises an outwardly convex flexible end on such catheter outer sleeve and such outwardly-swivelable connection comprises a partial planar cut separating, except for a remaining transverse hinge portion, such outwardly convex flexible end from such catheter outer sleeve, whereby such end cap comprises a planar internal surface; and, further, wherein said partial planar cut comprises an angle between such planar internal surface and a transverse plane perpendicular to a longitudinal axis of such longitudinal hollow of from about 0 degrees to about 45 degrees; and, further, wherein said angle is from about fifteen degrees to about twenty degrees.
Even in addition, according to a preferred embodiment thereof, this invention provides a catheter system for single-person implanting of an embryo in a uterus, comprising, in combination, the steps of: providing a wire-stiffened catheter outer sleeve having a longitudinal cylindrical hollow between a sleeve proximal end and a sleeve distal end, wherein a proximal portion of such cylindrical hollow has a larger internal diameter than an internal diameter of a distal portion of such cylindrical hollow; providing an inner catheter having a catheter proximal end and a catheter distal end having an opening for transmission of a such embryo, such catheter being sized for moving through such longitudinal cylindrical hollow, wherein a proximal portion of such inner catheter has a greater catheter wall thickness than a distal portion of such inner catheter, and wherein such proximal portion of such inner catheter has a larger external diameter than an external diameter of such distal portion of such inner catheter, and said inner catheter being structured and arranged to supportingly fit within such outer sleeve, thereby providing substantially greater catheter system stiffness; affixing a syringe at such proximal end of such inner catheter; loading such embryo into such inner catheter distal end; placing such inner catheter into such proximal end of such outer sleeve and moving such inner catheter forward until such inner catheter distal end is approaching such sleeve distal end; introducing such sleeve proximal end into a cervix to a desired stop location; further moving such inner catheter forward into such end cap of such outer sleeve, outwardly swiveling such end cap, and further moving such catheter distal end forward into access to the uterus to a desired implanting location; and flushing such embryo out of such catheter distal end.
It also provides such a catheter system wherein, during such step of further moving such inner catheter forward, forward travel of such inner catheter is limited by a distal end of such proximal portion of such inner catheter being blocked when reaching a distal end of such proximal portion of such outer sleeve, thereby assisting in avoiding injury to the uterus from too much forward travel of such inner catheter; and, further, wherein such step of moving such inner catheter forward may be accomplished by one hand of a catheter system user because of such substantially greater catheter system stiffness.
And it also provides a described catheter system wherein such inner catheter means further comprises, located adjacent such proximal end of such inner catheter means, indicator means for indicating a direction of opening of such side port. It also provides a described catheter system wherein such catheter outer sleeve further comprises a bend in such distal portion of such catheter outer sleeve to better assist in pushing through the cervix; and, further, wherein such catheter outer sleeve further comprises, located adjacent such proximal end of such catheter outer sleeve, indicator means for indicating a direction of such bend of such distal portion of such catheter outer sleeve. And it also provides a described catheter system wherein such swivel means is constructed and arranged in such manner that such end cap means swivels back to a closed position when such catheter sleeve means is pulled from the cervix.